MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the pusher wire and introducer sheath were returned for evaluation; however, the main coil was not returned.The introducer sheath was inspected and no anomalies were noted.The twist lock has been opened.The pusher wire was returned outside of the introducer sheath in good condition.No damages were observed.Microscopic inspection noted a smooth surface on the proximal end of the pusher wire.No issues were noted as well on the interlocking arm.Dimensional inspection of the pusher wire were also within specification.
Event or Problem Description
Reportable based on device analysis completed on 14-jun-2019.It was reported that the coil could not be delivered and deployed prematurely in the microcatheter.The target area was located in a moderately tortuous and mildly calcified internal iliac artery.A 2mm x 4cm interlock was selected for an embolization procedure.During procedure, the coil could not be delivered to the target area and subsequently, prematurely deployed inside the microcatheter.The physician was able to remove the coil within the catheter and both devices were removed from the patient's body.The procedure was completed with a different device.No patient complications were reported.However, device analysis noted that the mail coil was not returned.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8764557
• Report Number: 2134265-2019-07856
• Device Sequence Number: 14112812
• Product Code: KRD
• UDI-Device Identifier: 08714729845263
• UDI-Public: 08714729845263
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022355327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR